Hearing Loss, SensorineuralNCT06700512
Standard Post Market Clinical Follow-up (PMCF) Study WSA @ HZO
A study testing Hearing Aid Signia Pure C&G 7IX and Own Hearing Aid in people with Hearing Loss, Sensorineural, run by WSAUD A/S at 1 site in Germany.
Trial summary
The purpose of the study is to follow-up on a released low-risk device as part of standard PMCF activities Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hearing Loss, Sensorineural
- What is being tested?
- Hearing Aid Signia Pure C&G 7IX and Own Hearing Aid
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- 14 Jun 2024to 26 Aug 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hearing loss should fall within fitting range of study hearing aid
- They should be experienced hearing aid users
- Air-Bone-Gap should be less or equal to 20 dB Hearing Loss (HL).
- Sensorineural HL, mild-to-moderate
- HL corresponding to the fitting range of the hearing aid
- Healthy (outer) ear
Show all 11Show fewer
- Older than 18 years
- German is mother tongue
- Able to understand the instructions
- Willing to participate in laboratory tests and to wear the hearing aids at home for 2 weeks
- Informed consent
Who cannot join
- Contraindication for hearing aid treatment
- Fluctuating or rapidly progressing hearing loss
- "Central" hearing problems
- Limited mobility
- Limited dexterity (in handling the hearing aid)
- Known psychological problems
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Standard PMCF Study WSA @ HZO
The purpose of the study is to follow-up on a released low-risk device as part of standard PMCF activities
Read the detailed description
This is a comparative study which is conducted monocentric at Hoerzentrum Oldenburg, Germany. The focus is to test a released hearing aid and compare this to the subject's own hearing aids with a minimum of 16 mild-to-moderate sensorineural hearing impaired adult subjects. The subjects, all of them native German speakers, have 2 appointments of 1-2 hours including a fitting procedure with real-ear measurements and some standard speech tests and undergo two 2-weeks home trials (with questionnaires).
- Conditions
- Hearing Loss, Sensorineural
- Being tested
- Hearing Aid Signia Pure C&G 7IX, Own Hearing Aid
- Keywords
- Hearing aid, Freiburger, Matrix Test, SSQ, IOI-HA
- Medical subject headings
- Hearing Loss, Sensorineural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hearing Aid Signia Pure C&G 7IXDevice
Receiver in Canal (RIC) hearing aid, M Receiver
Own Hearing AidDevice
subjects' own hearing aids, any brand, any model
| Study group | Role | What they receive |
|---|---|---|
| Evaluation of Study Device followed by Own devices | Experimental | within subject design: Subjects wear the study devices for 2 weeks followed by wearing their own hearing aids for 2 weeks. Study devices are fitted as per standard-of-care. Receives: Device: Hearing Aid Signia Pure C&G 7IX; Device: Own Hearing Aid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oldenburg Sentence Test
The Oldenburg Sentence Test (OLSA) is an audiometric test for determining the speech recognition threshold (SRT in dB). Sentences of the form name - verb - numeral - adjective - noun are used as speech material. The sequence of words is a random combination from an inventory of 50 words in total. The design of the test prevents memorization of the sentences, so the OLSA can be repeated as often as desired. For this study speech in noise recognition was measured. Noise level was 65 dB SPL played from the back, speech was presented from front. The SRT shows the signal-to-noise ratio needed for 80% speech recognition. Lower values mean better speech understanding (i.e. the speech can be quieter with respect to the noise and still be understood). There are no minimum or maximum values.
Measured: Estimated Time Frame 2 weeks (Test conducted at second lab session).
Secondary outcomes (5)
Freiburger Monosyllabic Speech Test
To investigate speech intelligibility (SI) performance for speech at 65dB in a quiet listening situation, the Freiburger monosyllabic speech test is used which is still the gold standard for Hearing Care Professionals (HCPs) in Germany. Results are reported in Percent correct data. Minimum is 0%, maximum is 100% with higher values meaning better speech understanding.
Measured: Estimated Time Frame 2 weeks (Test conducted at second lab session).
Match-to-Target
Investigate how close the study hearing aids fitted and fine-tuned with the fitting software to NAL-NL2 Targets match the postulated targets, as measured in-situ with real-ear measurements. Absolute deviations were calculated at specific frequencies ranging from 250 Hz to 4 kHz. Unit of measure is dB SPL. Minimum Value is 0 (i.e. measured value and target value identical), no maximum value. Higher values mean greater deviation from target.
Measured: 1 day (Fitting procedure with real-ear measurements is done at first lab session)
Speech, Spatial and Qualities of Hearing Questionnaire (SSQ)
A short form of the SSQ is used (SSQ 17, German version), to investigate speech perception, sound localisation, quality of hearing perceived in real-life. Questions are answered on a scale from 0 to 10, higher scores mean better outcomes. The responses to the individual questions are grouped for the subsections (speech, spatial, quality) by calculating the means.
Measured: 2 weeks
International Outcome Inventory for Hearing Aids (IOI-HA)
Investigate outcomes and effectiveness of hearing aid usage in real-life. Responses are given on a scale from 1 - 5. Here, the mean of questions 2 -7 is reported. Higher values represent better outcomes. Question 1 was on wearing time, which is not considered a rating of effectiveness and was therefore excluded from the mean and will be reported separately. Fpr wearing times higher values represent longer wearing time (maximum 5 equals "more than 8 hours a day").
Measured: 2 weeks
Satisfaction Questionnaire
Investigate satisfaction in real-life for different aspects such as sound quality, naturalness of sound, conversation with one person and overall satisfaction. Each aspect was assessed on on a 7-point likert scale, going from 1 (very dissatisfied) to 7 (very satisfied) The overall satisfaction and sound quality overall were individual questions and are not the combination of different situations/aspects. These questions were also assessed on on a 7-point likert scale, going from 1 (very dissatisfied) to 7 (very satisfied). Higher values represent better outcomes.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2024
- Study start14 Jun 2024
- Primary completion13 Aug 2024
- Study completion26 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hearing Loss, SensorineuralStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- WSAUD A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Matthias Vormann, PhD, Principal investigator, Hörzentrum Oldenburg gGmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06700512
- Sponsor's protocol ID
- D00325215
- Status last verified
- Jul 2025
- First submitted
- 18 Nov 2024
- Last updated
- 8 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Standard PMCF Study WSA @ HZO
- ClinicalTrials.gov ID
- NCT06700512
- Acronym / sponsor ID
- D00325215
- Conditions
- Hearing Loss, Sensorineural
- Keywords
- Hearing aid, Freiburger, Matrix Test, SSQ, IOI-HA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- WSAUD A/SIndustry (pharma, biotech, devices)
- Study start
- 14 Jun 2024 (actual)
- Primary completion
- 13 Aug 2024 (actual)
- Study completion
- 26 Aug 2024 (actual)
- First posted
- 22 Nov 2024 (actual)
- Results
- Posted 8 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to follow-up on a released low-risk device as part of standard PMCF activities
Detailed description
This is a comparative study which is conducted monocentric at Hoerzentrum Oldenburg, Germany. The focus is to test a released hearing aid and compare this to the subject's own hearing aids with a minimum of 16 mild-to-moderate sensorineural hearing impaired adult subjects. The subjects, all of them native German speakers, have 2 appointments of 1-2 hours including a fitting procedure with real-ear measurements and some standard speech tests and undergo two 2-weeks home trials (with questionnaires).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Evaluation of Study Device followed by Own devices | Experimental | Device: Hearing Aid Signia Pure C&G 7IX, Device: Own Hearing Aidwithin subject design: Subjects wear the study devices for 2 weeks followed by wearing their own hearing aids for 2 weeks. Study devices are fitted as per standard-of-care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Hearing loss should fall within fitting range of study hearing aid
- They should be experienced hearing aid users
- Air-Bone-Gap should be less or equal to 20 dB Hearing Loss (HL).
- Sensorineural HL, mild-to-moderate
- HL corresponding to the fitting range of the hearing aid
Key exclusion criteria (6 listed)
- Contraindication for hearing aid treatment
- Fluctuating or rapidly progressing hearing loss
- "Central" hearing problems
- Limited mobility
- Limited dexterity (in handling the hearing aid)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hearing Aid Signia Pure C&G 7IXReceiver in Canal (RIC) hearing aid, M Receiver | Device | Evaluation of Study Device followed by Own devices |
| Own Hearing Aidsubjects' own hearing aids, any brand, any model | Device | Evaluation of Study Device followed by Own devices |
Primary outcome
Oldenburg Sentence Test
Time frame: Estimated Time Frame 2 weeks (Test conducted at second lab session).
The Oldenburg Sentence Test (OLSA) is an audiometric test for determining the speech recognition threshold (SRT in dB). Sentences of the form name - verb - numeral - adjective - noun are used as speech material. The sequence of words is a random combination from an inventory of 50 words in total. The design of the test prevents memorization of the sentences, so the OLSA can be repeated as often as desired. For this study speech in noise recognition was measured. Noise level was 65 dB SPL played from the back, speech was presented from front. The SRT shows the signal-to-noise ratio needed for 80% speech recognition. Lower values mean better speech understanding (i.e. the speech can be quieter with respect to the noise and still be understood). There are no minimum or maximum values.
5 secondary outcomes
Freiburger Monosyllabic Speech Test
Time frame: Estimated Time Frame 2 weeks (Test conducted at second lab session).
Match-to-Target
Time frame: 1 day (Fitting procedure with real-ear measurements is done at first lab session)
Speech, Spatial and Qualities of Hearing Questionnaire (SSQ)
Time frame: 2 weeks
International Outcome Inventory for Hearing Aids (IOI-HA)
Time frame: 2 weeks
Satisfaction Questionnaire
Time frame: 2 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthias Vormann, PhD principal investigator
Hörzentrum Oldenburg gGmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hearing Aid Signia Pure C&G 7IX and Own Hearing Aid in people with Hearing Loss, Sensorineural, run by WSAUD A/S at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oldenburg Sentence Test (time frame: Estimated Time Frame 2 weeks (Test conducted at second lab session).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2025.